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Biocides news

This page contains details of recent regulatory decisions and general news relating to the regulation of biocide products.

Information on significant historical regulatory decisions can be found in our archive.


EU Biocides Regulation 528/2012 - Active Substance Approval

The active substances in the first table below have been evaluated under the EU Biocides Regulation 528/2012 (EU BPR) and will be approved for use on the EU market on the dates shown.

Biocidal products containing these active substances will need to obtain EU BPR authorisation if they are to remain on the market.  

All affected companies must apply for UK product authorisation by the active substance approval dates (shown in the table) in order to keep their biocidal products on the UK market. Please note, if your biocidal product contains more than one active substance, the date by which you have to apply for product authorisation will be the date the last active substance in the product is approved. 

If no application for product authorisation in the UK is made by the approval dates, the biocidal product shall no longer be made available on the UK market after the dates indicated in the 3rd column. Disposal and use of existing stocks of the biocidal product may continue until dates indicated in the 4th column.  If the biocidal product has approval under the UK Control of Pesticides Regulations (COPR) its approval will be revoked.

Table 1: Active Substances Approval Dates
Active Substance Date of Approval Date when no longer to be made available on UK market if no application received Last date for disposal and use if no application received
Bacillus thuringiensis subsp. kurstaki, serotype 3a3b, strain ABTS-351 (PT 18) 1/3/2017 28/8/2017 1/3/2018
Cyfluthrin (PT 18) 1/3/2018 28/8/2018 1/3/2019
Citric acid (PT 2) 1/3/2018 28/8/2018 1/3/2019
Chlorocresol (PT’s 1, 2, 3, 6,9 & 13) 1/5/2018 28/10/2018 1/5/2019
Burnt dolomitic lime (PT’s 2 & 3) 1/5/2018 28/10/2018 1/5/2019
Burnt lime (PT’s 2 & 3) 1/5/2018 28/10/2018 1/5/2019
Hydrated dolomitic lime (PT’s 2 & 3) 1/5/2018 28/10/2018 1/5/2019
Hydrated lime (PT’s 2 & 3) 1/5/2018 28/10/2018 1/5/2019
Cocoalkyltrimethylammonium chloride (ATMAC/TMAC) (PT 8) 1/5/2018 28/10/2018 1/5/2019

The actives substances in the table below were previously evaluated under the EU Biocides Regulation 528/2012 (EU BPR). This is a reminder that they will be approved for use on the EU market on the dates shown and the advice above the previous table also applies to these actives:

Table 2: Active substance Approval Dates
Active Substance Date of Approval Date when no longer to be made available on UK market if no application received Last date for disposal and use if no application received
Hexaflumuron (PT18) 1/4/2017 28/9/2017 1/4/2018
Formaldehyde released from N,N-Methylenebismorpholine (PT's 6 and 13) 1/4/2017 28/9/2017 1/4/2018

Guidance for applying for product authorisation in the UK can be found in our EU BPR product authorisation section of the HSE biocides website. Guidance is also available there on the transitional arrangements for existing biocidal products on the UK market including products currently regulated under the COPR, which are affected by the approval of the above active substance.  
The full Union list of approved biocidal active substances, including links to the approval decisions and assessment reports can be found on the ECHA website. 

Published 25 November 2016


Biocides Regulation 528/2012 (EU BPR) – Public Consultation on Potential Candidates for Substitution

Under the EU Biocides Regulation 528/2012 (EU BPR), if the evaluating Competent Authority concludes in its evaluation that an active substance meets the criteria for substitution of Article 10 (1) of EU BPR, before submitting its opinion to the Commission on the approval or renewal of the approval of an active substance, the European Chemicals Agency (ECHA) will make publicly available information on the active substances identified as potential candidates for substitution. 

ECHA has launched public consultations on: 

3,3’-methylene-bis[5-methyloxazolidine] (oxazolidin/MBO), an active substance in PT’s 2, 6, 11, 12 & 13 ,and
α,α′,α″-trimethyl-1,3,5-triazine-1,3,5(2H,4H,6H)-triethanol (HPT), an active substance in PT’s 2, 6 11 & 13

The deadline for providing information is 3 January 2017. The information received, if not confidential, will be published during these public consultations. Please respond direct to ECHA and not to HSE.

When the consultation period is over, ECHA will process the information received and will take account of the information when finalising the opinion on the above substances in the Biocidal Products Committee (BPC).

Further information on active substances that are candidates for substitution can be found on ECHA’s website.

Further information about the BPC can be found on ECHA’s website

Published 25 November 2016


Classification and Labelling - Registry of Intentions

ECHA (at the request of the Commission) or Member States may prepare dossiers for the identification of substances of very high concern (SVHCs) and dossiers proposing restrictions (Annex XV of REACH). Dossiers proposing harmonised classification and labelling of substances may be prepared by Member State Competent Authorities and manufacturers, importers or downstream users.

The aim of the public Registry of Intentions (RoI) is to make interested parties aware of the substances for which a CLH, SVHC (Substance of Very High Concern),  or restriction dossier is intended to be submitted. This therefore gives the interested parties time to prepare for commenting later in the respective process. It also avoids duplication of work and encourages cooperation between potential dossier submitters.

The following intentions have been published:

Ozone - A new CLH intention to submit was submitted by Germany (Current CLH intentions);
Zinc pyrithione – A new CLH dossier was submitted by Sweden (Submitted CLH proposals).

Published 25 November 2016


EU Biocides Regulation 528/2012 - Active Substance(s) Approval(s)

The following active substance has been evaluated under the EU Biocides Regulation 528/2012 (EU BPR):

It will be approved for use in biocidal products placed on the EU market, on 1 February 2017. Biocidal products containing this active substance will therefore need to obtain EU BPR authorisation if they are to remain on the market.

All affected companies are reminded that they must apply for UK product authorisation by 1 February 2017 in order to keep their biocidal products on the UK market after the active substance approval date, 1 February 2017. Please note if your biocidal product contains more than one active substance the date by which you have to apply for product authorisation will be the date the last active substance in the product is approved.

If no application for product authorisation in the UK is made by 1 February 2017 for a biocidal product containing this active substance, the biocidal product shall no longer be made available on the UK market after 31 July 2017. Disposal and use of existing stocks of the biocidal product may continue until 1 February 2018.  If the biocidal product has approval under the UK Control of Pesticides Regulations (COPR) its approval will be revoked.

Guidance for applying for product authorisation in the UK can be found in our EU BPR product authorisation section of the HSE biocides website. Guidance is also available there on the transitional arrangements for existing biocidal products on the UK market including products currently regulated under the COPR, which are affected by the approval of the above active substance(s). 

The full Union list of approved biocidal active substances, including links to the approval decisions and assessment reports can be found on the ECHA website.

Published 22 September 2016


Food & Feed Active Substances – deadline for notification for inclusion in the EU Biocidal Products Regulation (EU BPR) review programme

Background

Where a biocidal product based on food or feed active substances had originally benefitted from a derogation under the Biocidal Products Directive review programme, industry had to make a declaration of an ‘Interest to Notify’ the active substances for inclusion in the EU Biocidal Products Regulation review programme.

Those declarations had to be made to the European Chemicals Agency (ECHA) by 30 October 2015.

ECHA have now assessed the declarations and have published a list of the 20 substances that are eligible to be notified for inclusion in the review programme as Product Type 19 attractants or repellents. Further details and the list of the eligible substances are available on the ECHA website.

Biocidal products, which had benefitted from a derogation, containing substances for which no valid declaration of interest to notify was submitted to ECHA by the deadline, and which were not included on the list on the ECHA website, will no longer be allowed to be made available on the EU market after 30 October 2016 and can no longer be used after 30 April 2017.

What action does Industry need to take now?

Industry will now have to officially notify the eligible active substances (in accordance with Article 17 of the EU BPR Review Regulation (1062/2014)) to ECHA by 24 February 2017 using IUCLID 6 and the biocides submission tool, R4BP 3. 

The European Commission will have the final decision on whether to include a substance in the Review Programme.

If no valid notification is received by the deadline, the corresponding products containing those substances will have to be removed from the market within 12 months from ECHA’s publication of the list of these substances.

See also: Derogation for foodstuff based repellents and attractants webpage

Published 8 September 2016


ECHA publication consultation - Eight anticoagulant rodenticide active substances

The European Chemicals Agency (ECHA) is collecting information to help the European Commission and Member States decide whether to renew the approval of eight anticoagulant rodenticide active substances (chlorophacinone, coumatetralyl, warfarin, bromadiolone, difenacoum, brodifacoum, difethialone and flocoumafen).

These eight anticoagulant rodenticide active substances (chlorophacinone, coumatetralyl, warfarin, bromadiolone, difenacoum, brodifacoum, difethialone and flocoumafen) have  specific hazard classes defined in Article 5 (1) of the EU Biocidal Products Regulation (BPR) and cannot be approved for use in biocidal products unless they meet specific derogation criteria described in Article 5(2) of the BPR.

ECHA is looking for information on the following criteria related to the risk to humans, animals or the environment, which need to be met if the approvals for these substances are to be renewed: 

The public consultation lasts for 60 days. Comments should be submitted to ECHA using the dedicated webform by 12 September 2016. If any of the information you provide is confidential, you will need to justify it – otherwise it will be published online. The European Commission, together with Member States, will take into account the information collected when deciding whether to renew the approvals of these eight active substances.

Please respond direct to ECHA and not to HSE.
Further information is provided in their news item. 

Published 26 July 2016


EU Biocides Regulation 528/2012 - Active Substance Approval

The following active substance has been evaluated under the EU Biocides Regulation 528/2012 (EU BPR):

It will be approved for use in biocidal products placed on the EU market, on 1 January 2017. Biocidal products containing this active substance will therefore need to obtain EU BPR authorisation if they are to remain on the market.

All affected companies are reminded that they must apply for UK product authorisation by 1 January 2017 in order to keep their biocidal products on the UK market after the active substance approval date, 1 January 2017. Please note if your biocidal product contains more than one active substance the date by which you have to apply for product authorisation will be the date the last active substance in the product is approved.

If no application for product authorisation in the UK is made by 1 January 2017 for a biocidal product containing this active substance, the biocidal product shall no longer be made available on the UK market after 30 June 2017. Disposal and use of existing stocks of the biocidal product may continue until 1 January 2018.  If the biocidal product has approval under the UK Control of Pesticides Regulations (COPR) its approval will be revoked.

Guidance for applying for product authorisation in the UK can be found in our EU BPR product authorisation section of the HSE biocides website. Guidance is also available there on the transitional arrangements for existing biocidal products on the UK market including products currently regulated under the COPR, which are effected by the approval of the above active substance. 

The full Union list of approved biocidal active substances, including links to the approval decisions and assessment reports can be found on the ECHA website.

Published 18 July 2016


EU Biocides Regulation 528/2012 - Active Substance(s) Approval(s)

The following active substance(s) have been evaluated under the EU Biocides Regulation 528/2012 (EU BPR):

They will be approved for use in biocidal products placed on the EU market, on 1 December 2016. Biocidal products containing these active substance(s) will therefore need to obtain EU BPR authorisation if they are to remain on the market.

All affected companies are reminded that they must apply for UK product authorisation by 1 December 2016 in order to keep their biocidal products on the UK market after the active substance approval date, 1 December 2016. Please note if your biocidal product contains more than one active substance the date by which you have to apply for product authorisation will be the date the last active substance in the product is approved.

If no application for product authorisation in the UK is made by 1 December 2016 for a biocidal product containing these active substance(s), the biocidal product shall no longer be made available on the UK market after 30 May 2017. Disposal and use of existing stocks of the biocidal product may continue until 1 December 2017.  If the biocidal product has approval under the UK Control of Pesticides Regulations (COPR) its approval will be revoked.

Guidance for applying for product authorisation in the UK can be found in our EU BPR product authorisation section of the HSE biocides website. Guidance is also available there on the transitional arrangements for existing biocidal products on the UK market including products currently regulated under the COPR, which are effected by the approval of the above active substance(s). 

The full Union list of approved biocidal active substances, including links to the approval decisions and assessment reports can be found on the ECHA website.

Published 30 June 2016


UK position on the status under the Biocidal Products Regulation 528/2012 (BPR) of barley straw for the purposes of controlling blanket weed and other algae in lakes and ponds

Barley straw products have been marketed for the purposes of controlling blanket weed and other algae in lakes and ponds for some time. Barley straw is naturally occurring, and subject to ‘processing’ only so far as is necessary to harvest, chop and bag it before being sold for small-scale uses to treat e.g. fish tanks and ponds. The UK considers that barley straw is not a biocidal product under the EU Biocidal Products Regulations (BPR), and has gained support for that position.

The UK position is based on the definition in the BPR of “biocidal product” as a “substance” or a “mixture”. Given an interpretation of the EU REACH chemicals legislation by the European Chemicals Agency, the UK case is that barley straw is not a substance or mixture as defined, is out of scope of the BPR and does not need to be authorised to allow its continued use, for example to control algal growth in garden ponds.

HSE was considering seeking a formal decision under Article 3(3) of the BPR on the status of barley straw. We have revisited our position in the light of the Commission Implementing Decision (EU) 2016/678 of 29 April 2016 on dried lavender blossoms contained in a pad placed on the market to repel moths, that the product is neither a biocidal product nor a treated article for the purposes of Article 3(1)(a) and (l) of the Biocidal Products Regulation. Having consulted the EU Commission on how best to proceed, the UK considers that the recent decision on lavender blossom makes it clear that untreated Barley Straw is neither a biocidal product nor a treated article, on the same grounds as those set out for lavender blossom, and so is not in scope of the BPR. The UK will rely on this precedent to support its position, and so will not be submitting a request for a formal decision under Article 3(3) of the BPR. We have written in these terms to the other Member States setting out the UK position, copying it to the EU Commission.

These developments and the scenario above do not however extend to barley straw extract, as this does not meet the above conditions for unprocessed barley straw. Anyone wishing to support barley straw extract as an active substance or biocidal product will still need to provide the required data for evaluation.

Published 20 June 2016


EU Biocides Regulation 528/2012 (EU BPR) – ECHA’s open invitations following withdrawal of support for sodium p-chloro-m-cresolate for product types 1, 2, 3, 6, 9 and 13 from the biocides active substance review programme

The following active substance/product type combinations are no longer considered to be supported in the biocides active substance review programme:

The European Chemicals Agency (ECHA) has published an open invitation, which allows interested companies to take over the role of participant for the above active substance/product type combinations.

Interested companies should complete the notification procedure in Article 17 of the Review Regulation by the 25 May 2017. Notifications should be submitted to the European Chemicals Agency (ECHA), via R4BP.

If no-one takes over the role of participant, these active substance/product type combinations will be subject to a non-approval decision and products containing them for the affected product types will have to be removed from the market.

Published 20 June 2016


EU Biocides Regulation 528/2012 (EU BPR) – ECHA’s open invitations following withdrawal of support for 6-(phthalimido)peroxyhexanoic acid (PAP) for product types 3 and 4

The following active substance/product type combinations are no longer considered to be supported in the biocides active substance review programme:

The European Chemicals Agency (ECHA) has published an open invitation, which allows interested companies to take over the role of participant for the above active substance/product type combinations.

Interested companies should complete the notification procedure in Article 17 of the Review Regulation by the 27 April 2017. Notifications should be submitted to the European Chemicals Agency (ECHA), via R4BP.

If no-one takes over the role of participant, these active substance/product type combinations will be subject to a non-approval decision and products containing them for the affected product types will have to be removed from the market.

Details of other open invitations where all participants have withdrawn their support or the active substance has been redefined can be found on the ECHA website.

Published 2 June 2016


EU Biocides Regulation 528/2012 (EU BPR) – ECHA’s open invitations following withdrawal of support for pyridine-2-thiol 1-oxide, sodium salt (sodium pyrithione) for product type 3 and cetylpyridinium chloride for product type 2 from the biocides active substance review programme

The following active substance/product type combinations are no longer considered to be supported in the biocides active substance review programme,

The European Chemicals Agency (ECHA) has published an open invitation, which allows interested companies to take over the role of participant for the above active substance/product type combinations.

Interested companies should complete the notification procedure in Article 17 of the Review Regulation by the 25 February 2017. Notifications should be submitted to the European Chemicals Agency (ECHA), via R4BP.

If no-one takes over the role of participant, these active substance/product type combinations will be subject to a non-approval decision and products containing them for the affected product types will have to be removed from the market.

Details of other open invitations where all participants have withdrawn their support or the active substance has been redefined can be found on the ECHA website.

Published 10 March 2016


EU Biocides Regulation 528/2012 (EU BPR) – Active Substance Non-Approval Implementing Decisions

The following active substances have been evaluated under the EU Biocides Regulation 528/2012 (EU BPR) and the EU Commission has decided not to approve them for use in biocidal product made available on the EU market.

It has also been decided not to approve

because all the participants have discontinued their participation from the biocides active substance review programme.

All affected companies are reminded that biocidal products containing these active substances, in the list product type,

Companies must manage the supply of the affected product to ensure there will be none remaining in the EU supply chain by 16 February 2017.

If the biocidal product was approval under the UK Control of Pesticides Regulations (COPR), affected companies will receive a certificate to revoke the COPR approval in line with the above dates.

Published 3 March 2016


EU Biocides Regulation 528/2012 (EU BPR) – ECHA’s open invitations following withdrawal of support for citric acid for product type 1 and chlorine dioxide generated from tetrachlorodecaoxide complex (TCDO) by acidification for product type 1 from the biocides active substance review programme

The following active substance/product type combinations are no longer considered to be supported in the biocides active substance review programme:

The European Chemicals Agency (ECHA) has published an open invitation, which allows interested companies to take over the role of participant for the above active substance/product type combinations.

Interested companies should complete the notification procedure in Article 17 of the Review Regulation by the 9 February 2017. Notifications should be submitted to the European Chemicals Agency (ECHA), via R4BP.

If no-one takes over the role of participant, these active substance/product type combinations will be subject to a non-approval decision and products containing them for the affected product types will have to be removed from the market.

Details of other open invitations where all participants have withdrawn their support or the active substance has been redefined can be found on the ECHA website

Published 3 March 2016


Updated 2016-12-01